NCT02736058

Brief Summary

Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly decrease the intra-operative complications as well as the maternal morbidity and mortality. In this trial researchers aim to set up some pre-operative sonographic criteria that would help in planning the surgical procedure as well as setting up a surgical classification for the abnormally adherent placenta.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

February 22, 2016

Last Update Submit

May 28, 2016

Conditions

Adherent Placenta

Outcome Measures

Primary Outcomes (1)

  • intraoperative blood loss

    24 hours

Study Arms (1)

Participants

EXPERIMENTAL

the included pregnant females will undergo trans-abdominal sonography as well as trans-vaginal sonography , to diagnose the abnormal placentation and the results will be compared to the intra- operative as well as the pathological examination of the specimen.

Device: Trans- abdominal sonographyDevice: Trans-vaginal sonographyProcedure: post-operative pathological specimen examination

Interventions

Trans- abdominal sonographyDEVICE
Participants
Trans-vaginal sonographyDEVICE
Participants
post-operative pathological specimen examinationPROCEDURE
Participants

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • abnormal placental site (placenta previa)

You may not qualify if:

  • refusal to participate in the study
  • cases with normal placental location ( fundal, anterior or posterior wall not reaching the lower uterine segment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el aini hospital

Cairo, Cairo Governorate, 12211, Egypt

RECRUITING

Study Officials

  • Ahmed M Hussein, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Hussein, MD

CONTACT

01223515652ahmed_mhussein@live.com

Dina M Dakhly, MD

CONTACT

01003498919dinadakhly@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 22, 2016

First Posted

April 13, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

EG(1)